BLASOLUTIONINJECTIONPriority Review
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
Priority Review
ENFLONSIA (clesrovimab) by Merck & Co. is fusion protein inhibitors [moa]. Approved for respiratory syncytial virus anti-f protein monoclonal antibody [epc]. First approved in 2025.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENFLONSIA (clesrovimab) is a monoclonal antibody that inhibits the fusion protein of Respiratory Syncytial Virus (RSV), preventing viral entry into respiratory cells. It is administered as an injection and represents a new therapeutic approach to RSV prevention. The drug is indicated for RSV infection prevention in susceptible populations.
Growth
As a newly launched RSV monoclonal antibody from Merck, the brand team will focus on establishing market presence against established competitors in a high-demand pediatric indication.
Mechanism of Action
Fusion Protein Inhibitors
Pharmacologic Class:
Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
The EMBRACE Study: Enflonsia Monoclonal in Babies - RSV Antibody Concentration Evaluation
Started Sep 2026
24 enrolled
RSV Infection
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Started Nov 2021
1,003 enrolled
RSV Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Started Apr 2021
3,632 enrolled
Respiratory Syncytial Virus Infection
Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
Started Oct 2019
80 enrolled
Respiratory Syncytial Viruses
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Started Sep 2018
183 enrolled
Respiratory Tract InfectionRespiratory Syncytial Virus
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.